USFDA Guidance on “Pharm. Quality/CMC Data Exchange" and Drug Products containing Nanoparticles

Draft PQ/CMC Data Exchange for Electronic Submission of PQ/CMC Data

On April 22 2022, USFDA, FDA has released the draft document, “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange,” which is focused on the representation of those published PQ/CMC structured data elements in the new health care data exchange standard from Health Level 7 (HL7), called Fast Health Interoperability Resources (FHIR).

To support the future electronic acquisition and use of submitted information, FDA has undertaken a project to identify and prioritize pharmaceutical quality (PQ) and chemistry and manufacturing and controls (CMC) information that would benefit from a structured submission approach.

Standardizing the format of structured data submission standardized format should increase the efficiency of FDA’s review of PQ/CMC data contained in the Module 3 of eCTD submissions across several application types.

FDA is currently seeking feedback and comments on how the PQ/CMC data elements are represented in HL7 FHIR.

Guidance on Drug Products, Including Biological Products, that Contain Nanomaterials

Nanotechnology may be used to create drug products in which nanomaterials serve a variety of functions, as active ingredients or inactive ingredients, including carriers loaded with an active ingredient. The inclusion of such materials may result in product attributes that differ from those of products that do not contain such materials, and thus may merit particular examination.

This document provides guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form.

FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale,” or other related terms but to know more on this guidance click this LINK